Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Stomach Neoplasms

Pancreatic Neoplasms

Stomach Cancer

Pancreatic Cancer

Stage I: Dose Escalation and dose expansion： Dose Escalation：SYSA1801 will be administered intravenously (IV) at different dose levels, including 0.5, 1, 2, 3, 4.5 and 6 mg/kg according to a modified 3+3 dose-escalation design. Accelerated dose titration design will be used for the first 2 dose levels (0.5 and 1 mg/kg), and then traditional 3+3 dose escalation design will be used for the following levels (2, 3, 4.5 and 6 mg/kg).

Dose expansion: SYSA 1801 will be administered at up to dose levels which is equal or lower than MTD IV infusion. Each dose level contains no more than 12 subjects (including subjects in dose escalation) Stage II: Extension cohort This cohort will comprise subjects with Claudin 18.2 positive GC or GEJ adenocarcinoma, pancreatic cancer or other solid cancer with prior failure of, progression on, or intolerance to, standard therapy.

The starting dose of SYSA1801 for expansion will be derived from the RP2D determined during Stage I

SYSA1801 will be administered intravenously (IV) on Day 1 of every 21-day cycle. Individual subjects may continue study treatment until there is evidence of disease progression (clinical or radiologic) judged by Investigators, unacceptable toxicity or other reasons for treatment discontinuation.

SYSA1801 for injection

Shen Lin, Ph.D

Gong Jifang, Ph.D

Gong Jifang, PhD.

This is an open-label, dose escalation, dose expansion and extension cohort phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of SYSA1801

This study includes two stages. The dose escalation and dose expansion part (Stage I) will determine the MTD and RP2D of SYSA1801 in subjects with advanced solid tumor for which there is no available standard likely to confer clinical benefit based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design) The extension cohort (Stage II) will evaluate the preliminary efficacy and safety of SYSA1801 in subjects with Claudin 18.2 positive gastric cancer (GC), gastroesophageal junction (GEJ) cancer, pancreatic cancer, non-small cell lung cancer and other solid tumors who have relapsed and/or are refractory to approved therapies.

Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor

A Phase I Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Initial Efficacy of SYSA1801 in the Treatment of CLDN 18.2 Positive Advanced Malignant Solid Tumor

DLT was defined as ≥grade 3 adverse events (per protocal and NCI CTCAE 5.0)related to the study drug that occurred in the first administration cycle (21 days) of SYSA1801

RP2D may be selected based on the Maximum tolerated dose(MTD), pharmacokinetic and antitumor activity data

The adverse events occurring or worsening on or after the first dose of the study drug will be recorded

Cmax of SYSA1801, total antibodies and free MMAE

Tmax of SYSA1801, total antibodies and free MMAE

AUC of SYSA1801, total antibodies and free MMAE

Antibodies against SYSA1801, including neutralizing antibodies

ORR was defined as the proportion of patients achieving either a confirmed complete response or partial response (PR), per RECIST v1.1

DCR is the proportion of patients with disease control (include patients with Complete response, partial response and stable disease)

PFS is defined as the time from the date of first administration to the date of the first documentation of progressive disease or death due to any cause, whichever occurs first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor	NCT05009966	Advanced Solid ... Gastric Cancer ... Gastroesophagea... Pancreatic Canc...	SYSA1801 for in...	18 Years - 75 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor	NCT05009966	Advanced Solid ... Gastric Cancer ... Gastroesophagea... Pancreatic Canc...	SYSA1801 for in...	18 Years - 75 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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